Modus Nav
K-Number: K183325 · 2019-07-14
ApplicantSynaptive Medical, Inc.
Decision Date2019-07-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Modus Nav is a medical device manufactured by Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2019-07-14 under approval number K183325. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Modus Nav?
Modus Nav is a medical device that received FDA 510(k) clearance on 2019-07-14. It is manufactured by Synaptive Medical, Inc.. The 510(k) number is K183325.
When was Modus Nav approved by the FDA?
Modus Nav received FDA 510(k) clearance on 2019-07-14, under approval number K183325.
What company makes Modus Nav?
Modus Nav is manufactured by Synaptive Medical, Inc..
What is the FDA product code for Modus Nav?
The FDA product code for Modus Nav is HAW.
Other Devices by Synaptive Medical, Inc.
Related Devices (Code: HAW)
K162604Cranial Reducing TubesMedtronic Navigation, Inc.
K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation
K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.
K152764EXACTECH GPSBlue Ortho
K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.
K151156Fiagon Navigation SystemFiagon GmbH
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.